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Plasmodium Falciparum Artemisinin Resistance Vietnam

Primary Purpose

Plasmodium Falciparum

Status

Completed

Phase

Phase 4

Locations

Vietnam

Study Type

Interventional

Intervention

Arterakin (DHA-PPQ)

About this trial

This is an interventional treatment trial for Plasmodium Falciparum focused on measuring P.f resistance

Eligibility Criteria

2 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: from 6 months of age;
Fever (body temperature above 37.5C) or history of fever in the previous 24 hours;
Mono-infection with P.falciparum with parasite density between 500-100,000/µl
Written informed consent to participate to the trial. For patients aged less than 18 years, an informed consent will be obtained from a parent or a guardian.

Exclusion Criteria:

Mixed malaria infection;
Pregnancy or lactation (urine test for β human chorionic gonadotropin to be performed on any woman of child bearing age unless menstruating);
Concomitant acute illness necessitating specific treatment (antibiotics);
Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS).
Severe malnutrition;
Danger signs:
- not able to drink
- incontrollable vomiting
- recent history of convulsions (>1 in 24 hours)
- unconscious state; neurological impairment
- unable to sit or stand
Signs of severe malaria:
1. Cerebral malaria (unrousable coma)
2. Severe anaemia (Htc< 15%)
3. Renal failure (serum creatinine > 3 mg/dL)
4. Pulmonary oedema;
5. Hypoglycemia (<40mg/dL)
6. Shock (systolic BP < 70 mmHg in adults, 50 in children)
7. Spontaneous bleeding
8. Repeat generalized convulsions
9. Macroscopic haemoglobinuria
10. Severe jaundice
Persons who have received quinine, artemisinin or artemisinin derivatives within the last 7 days, 4-aminoquinolines within the last 14 days, pyrimethamine and/or sulfonamides within the last 28 days, or mefloquine within the last 56 days should be excluded from the in vitro testing

Sites / Locations

Health Centre Tra Leng

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arterakin

Arm Description

Number of DHA- PPQ (Arterakin™) tablets per day at 0hour, 8hours, 24hours, 48hours (according to age): 2 - 3 years:0.5, 0.5, 0.5, 0.5 3 - < 8 years: 1.0, 1.0, 1.0, 1.0 8 - < 15 years:1.5, 1.5, 1.5, 1.5 ≥ 15 years:2.0, 2.0, 2.0, 2.0

Outcomes

Primary Outcome Measures

Parasite clearance time

Secondary Outcome Measures

efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam

treatment failure or success at day 42

in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province

MarkIII in vitro test

Full Information

NCT ID

NCT01775592

First Posted

January 11, 2013

Last Updated

January 25, 2013

Sponsor

National Institute of Malariology, Parasitology and Entomology, Vietnam

Collaborators

Institute of Tropical Medicine, Belgium

1. Study Identification

Unique Protocol Identification Number

NCT01775592

Brief Title

Plasmodium Falciparum Artemisinin Resistance Vietnam

Official Title

Monitoring the Efficacy of Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Traleng Commune, Central Vietnam

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Malariology, Parasitology and Entomology, Vietnam

Collaborators

Institute of Tropical Medicine, Belgium

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the successful treatment of malaria, has been confirmed in Cambodia. There are few reports from neighbouring countries about delayed parasite rates. The investigators therefore aim to assess parasite clearance in malaria patients in central Vietnam when treated according to national standard guidelines.

Detailed Description

General objective To evaluate the efficacy of DHA-PPQ in patients with uncomplicated falciparum malaria in a rural area of Central Vietnam, and to assess the in vitro susceptibility of P.falciparum isolates to DHA and PPQ. Specific objectives To measure the parasite clearance time in falciparum malaria patients treated with DHA-PPQ. To determine the efficacy of DHA-PPQ at day 42 post-treatment. To assess the in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province. To compare genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plasmodium Falciparum

Keywords

P.f resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arterakin

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Arterakin (DHA-PPQ)

Primary Outcome Measure Information:

Title

Parasite clearance time

Time Frame

Day 2-5

Secondary Outcome Measure Information:

Title

efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam

Description

treatment failure or success at day 42

Time Frame

Day 42

Title

in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province

Description

MarkIII in vitro test

Time Frame

Day 3-10

Other Pre-specified Outcome Measures:

Title

genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance

Description

genotyping

Time Frame

1year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: from 6 months of age; Fever (body temperature above 37.5C) or history of fever in the previous 24 hours; Mono-infection with P.falciparum with parasite density between 500-100,000/µl Written informed consent to participate to the trial. For patients aged less than 18 years, an informed consent will be obtained from a parent or a guardian. Exclusion Criteria: Mixed malaria infection; Pregnancy or lactation (urine test for β human chorionic gonadotropin to be performed on any woman of child bearing age unless menstruating); Concomitant acute illness necessitating specific treatment (antibiotics); Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS). Severe malnutrition; Danger signs: not able to drink incontrollable vomiting recent history of convulsions (>1 in 24 hours) unconscious state; neurological impairment unable to sit or stand Signs of severe malaria: Cerebral malaria (unrousable coma) Severe anaemia (Htc< 15%) Renal failure (serum creatinine > 3 mg/dL) Pulmonary oedema; Hypoglycemia (<40mg/dL) Shock (systolic BP < 70 mmHg in adults, 50 in children) Spontaneous bleeding Repeat generalized convulsions Macroscopic haemoglobinuria Severe jaundice Persons who have received quinine, artemisinin or artemisinin derivatives within the last 7 days, 4-aminoquinolines within the last 14 days, pyrimethamine and/or sulfonamides within the last 28 days, or mefloquine within the last 56 days should be excluded from the in vitro testing

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annette Erhart, MD, PhD

Organizational Affiliation

ITM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Health Centre Tra Leng

City

Tra Leng

State/Province

Quang Nam

Country

Vietnam

12. IPD Sharing Statement

Citations:

PubMed Identifier

25224002

Citation

Thriemer K, Hong NV, Rosanas-Urgell A, Phuc BQ, Ha do M, Pockele E, Guetens P, Van NV, Duong TT, Amambua-Ngwa A, D'Alessandro U, Erhart A. Delayed parasite clearance after treatment with dihydroartemisinin-piperaquine in Plasmodium falciparum malaria patients in central Vietnam. Antimicrob Agents Chemother. 2014 Dec;58(12):7049-55. doi: 10.1128/AAC.02746-14. Epub 2014 Sep 15.

Results Reference

derived

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Plasmodium Falciparum Artemisinin Resistance Vietnam

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